Changes in Endocrinological and Central Neuronal Satiety Regulation Following Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Functional magnetic resonance imaging following intravenous glucose infusion.
研究概览
简要总结
The overall aim of the proposed project is to investigate the contribution of changes in neuronal food processing, hypothalamic reactivity and hormonal factors to weight loss after bariatric surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •planning to undergo bariatric surgery
- •planning to take part in a conservative diet
排除标准
- •inability to undergo fMRI
- •psychiatric disorders
- •metabolic disorders
结局指标
主要结局
Change in Functional magnetic resonance imaging following intravenous glucose infusion.
时间窗: 2 weeks before surgery or start of dietary intervention and 2 weeks after surgery or start of dietary intervention.
Change in responsivity of the hypothalamus (extracted as percent signal change) as the core region of homeostatic control will be assessed after an intravenous glucose infusion (by calculating the area under the curve of hypothalamic responsivity) before and after bariatric surgery or dietary intervention.
Assessment of glucose-induced changes in peripheral ghrelin using blood samples.
时间窗: 15 minutes before and 15 minutes after functional magnetic resonance imaging
Blood is collected to measure the concentration of peripheral ghrelin as an indicator of hormonal satiety signaling. Blood samples are collected at the beginning and end of each experimental session to assess the influence of intravenuous infusion of glucose on ghrelin signaling. Blood samples will be analysed using using commercially available kits (enzyme-linked immunosorbent assay).
Experimental functional magnetic resonance imaging task (gustatory stimulation).
时间窗: 2 weeks before surgery or start of dietary intervention and 2 weeks after surgery or start of dietary intervention.
Neuronal gustatory processing of food stimuli will be assessed (ingestion of sweet liquids using a gustometer) using a general linear model (comparing brain activation during ingestion of sweet liquids with brain activation during the ingestion of water) and within as well as between groups analyses. Changes in neural gustatory processing of food stimuli will be assessed before and after bariatric surgery or dietary intervention.
次要结局
未报告次要终点
研究者
Joe Simon
Principal Investigator
University of Heidelberg Medical Center